The ECOG-ACRIN SUPPORT Trial: Multilevel Intervention to Improve Diverse Enrollment in Cancer Clinical Trials

摘要 临床试验的多样性不足被广泛认为是造成健康差距的重要因素。 在美国，少数族裔和其他不同的人群都经历过这种情况。这种平等的缺失要求我们迫切需要 旨在增加多样性的倡议，以支持更公平地代表临床研究和 让所有人公平地享受到临床研究带来的医疗进步带来的好处。美国国家癌症研究所 (NCI)支持的临床试验(CT)是癌症护理创新的关键驱动力；然而，种族/民族 少数族裔，特别是黑人和拉丁裔人口在NCI支持的社区中代表性不足，因此 不能充分受益于尖端治疗和精准医疗。布莱克和布莱克的CT参与 拉美裔人口继续短缺，结构、临床、医生和患者障碍众多 保证采取多层次干预措施，加强黑人和拉丁裔患者到NCI支持的转诊和登记 CTS.ECOG-ACRIN癌症研究小组(EA)作为NCORP研究基地，参与了社区 提供者和研究人员通过强大的研究组合，涵盖癌症控制、癌症预防、 和癌症护理服务。我们建议利用EA的集体资源，我们团队几十年来 改善临床试验多样性的工作，以及我们在患者导航和CT研究方面的基础工作 创建和评估ECOG-ACRIN试验支持工具包(支持干预)的扫盲工具 为了改善黑人和拉丁裔在头颈部NCI支持的活跃治疗试验中的转诊和登记情况， 胸癌、泌尿生殖道癌、白血病和骨髓瘤。多层次EA支持干预 由CT研究素养工具和位于EA的CT资源导航员组成，他们将与患者进行交互， 提供者和社区肿瘤学网站工作人员，以改善黑人和拉丁裔患者的转诊和登记 CTS.我们的具体目标是：1)进行初步评估并细化EA支持干预 重点放在社区代表性和投入上。2)实施混合型1群集--随机部署 有效性-在10个NCORP社区肿瘤学实践点(N=500个黑人和 拉丁裔癌症患者)评估电针支持干预在改善黑人方面的有效性 和拉丁裔患者转介和登记到NCI支持的CT(主要结果)以及参与者和提供者 在评估执行因素时对CT(次要成果)的认识和知识。3)使用 CUSP2CT数据、评估和协调中心，进行最终现场评估并传播 支持对NCORP社区肿瘤学网站、研究基地和附属试验网络的干预。我们的 协作基础设施和EA支持的多水平干预将改变当前的临床试验研究 以推荐和注册模式为基础，通过CT创新直接消除多层次的障碍 导航和CT研究扫盲工具。

ABSTRACT Inadequate diversity in clinical trials is widely recognized as a significant contributing factor to health disparities experienced by racial/ethnic minorities and other diverse populations in the US. This lack of parity calls for urgent initiatives aimed at increasing diversity in order to support more equitable representation in clinical research and bring the benefits of advances in healthcare forged by clinical research equitably to all. National Cancer Institute (NCI) supported clinical trials (CTs) are key drivers of innovations in cancer care; however racial/ethnic minorities, and Black and Latino populations in particular, are underrepresented in NCI-supported CTs and thus not able to fully benefit from cutting edge treatments and precision medicine. CT participation among Black and Latino populations continues to fall short and the multitude of structural, clinical, physician, and patient barriers warrant multilevel interventions to enhance referral and enrollment of Black and Latino patients to NCI-supported CTs. The ECOG-ACRIN Cancer Research Group (EA), as an NCORP Research Base, has engaged community providers and researchers through a robust research portfolio that spans Cancer Control, Cancer Prevention, and Cancer Care Delivery. We propose to leverage the collective resources of the EA, our team’s decades of work on improving diversity in clinical trials, and our foundational work in patient navigation and CT research literacy tools to create and evaluate an ECOG-ACRIN Trial SUPPORT Toolkit (SUPPORT intervention) that aims to improve Black and Latino referral and enrollment in active NCI-supported therapeutic trials in head and neck, thoracic, and genitourinary cancers, and leukemia and myeloma. The multilevel EA SUPPORT intervention consists of a CT research literacy tool and CT Resource Navigators based at EA who will interface with patients, providers, and community oncology site staff to improve referral and enrollment of Black and Latino patients to CTs. Our specific aims are to: 1) Conduct preliminary assessments and refine the EA SUPPORT intervention with focus on community representation and input. 2) Conduct a Hybrid Type 1 cluster-randomized, roll-out effectiveness-implementation trial in 10 NCORP community oncology practice sites (with N= 500 Black and Latino patients with cancer) to evaluate the effectiveness of the EA SUPPORT intervention in improving Black and Latino patient referral and enrollment to NCI-supported CTs (primary outcomes) and participant and provider awareness and knowledge of CTs (secondary outcomes) while assessing implementation factors. 3) With the CUSP2CT Data, Evaluation, and Coordinating Center, conduct final site evaluation and disseminate the SUPPORT intervention to NCORP community oncology sites, research bases, and affiliated trial networks. Our collaborative infrastructure and EA SUPPORT multilevel intervention will shift the current clinical trial research base referral and enrollment paradigm and directly remove multiple levels of barriers through innovations in CT navigation and CT research literacy tools.